A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis
NCT ID: NCT05765435
Last Updated: 2025-07-03
Study Results
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View full resultsBasic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2023-06-27
2023-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
12-week exercise and walking program
The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions.
12-week exercise and walking program
The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
NMES and FES
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions.
12-week exercise and walking program
The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
FES
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
Interventions
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12-week exercise and walking program
The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
FES
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Ability to walk a duration of 30 minutes per walking session (with or without an assistive device), for three days per week
3. Able to tolerate the device for up to 1 hour per lab session
4. No recent change in medication or exacerbation of symptoms over the last 60 days
5. Radiographic KOA Kellgren and Lawrence grade 2 or 3 or physician diagnosed mild or moderate KOA if radiographic imaging is not available
6. No hyaluronic acid or cortisone injection into knees in previous 12 months
Exclusion Criteria
2. Absent sensation in the impacted or more impacted leg
3. Inadequate response to stimulation, as defined as inability to achieve muscle contraction or tolerate stimulation
4. Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
5. Use of FES devices in the past year
6. Demand-type cardiac pacemaker or defibrillator
7. Malignant tumor in the impacted or more impacted leg
8. Existing thrombosis in the impacted or more impacted leg
9. Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
10. History of knee replacement surgery
11. History of other types of arthritis
12. History of neurological disease
13. History of seizures or diagnosed with epilepsy/seizures
14. Current pregnancy
22 Years
75 Years
ALL
No
Sponsors
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Cionic, Inc.
INDUSTRY
Responsible Party
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Rebecca Webster
Director of Clinical Operations and Research
Locations
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Cionic, Inc.
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CIONIC-05-001
Identifier Type: -
Identifier Source: org_study_id
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